Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets

Part of paid clinical trials in West Point, New York.

Sponsor
Keller Army Community Hospital
Study ID
NCT06341868
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex
ALL
Age
17 Years - 27 Years
Healthy Volunteers
Not accepted

Interventions

  • KneeStim — DEVICE
    Participant will be randomized to either be in control or experimental group

Study Details

The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are: * Examine the effects of KneeStim wear on cadets' post-operative gait * Examine changes in site-specific skeletal muscle mass * Examine the changes in patient-reported outcomes * Assess time to return to full duty * Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume) * Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture) Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks. Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned..

Key Dates

Start date
Sep 19, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Standard of Care + KneeStim controlled low intensity
    Low intensity range
  • Experimental: Standard of Care + KneeStim flexible intensity
    Flexible to high intensity range

Primary Outcome Measure

Change in gait post-operatively assessed by the KneeStimTM Device [ Time Frame: 6 weeks;3, 6, 9, 12 months post-operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Keller Army Community HospitalWest PointNew York10996
Natalia B Prando, MA
[email protected]
315-774-8368
Madison Mach, PhD
[email protected]
315-774-8368

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Keller Army Community Hospital· West Point, NY

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